BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR DISSECTION ELECTRODE

    MDR report key: 17127368 · Received June 14, 2023

    Report

    Report Number
    9610617-2023-00711
    Event Type
    Injury
    Date Received
    June 14, 2023
    Report Date
    June 12, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GCJ
    PMA / PMN Number
    K951986
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 20-0074 CORRECTIVE ACTION 6. THE ROOT CAUSE IS MOST LIKELY MECHANICAL OVERLOADING BY EXERTING TOO MUCH FORCE. NO INDICATIONS FOR A MATERIAL OR MANUFACTURING RELATED ISSUE WERE FOUND DURING THE INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID:(B)(4).

    Description of Event or Problem · 0

    NEEDLE OF THE INSTRUMENT IS BROKEN AND WAS LOST IN THE BODY (UTERUS). LUCKILY THEY FOUND IT AND THEY COULD CATCH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875081 BIPOLAR DISSECTION ELECTRODE BIPOLAR DISSECTION ELECTRODE GCJ KARL STORZ SE & CO. KG 26159BE SR02

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other